Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
Study Details
Study Description
Brief Summary
This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with rosacea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oxymetazoline + Energy-Based Therapy Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. |
Drug: Oxymetazoline HCL 1.0% Cream
Oxymetazoline HCl cream 1.0% once daily application
Other Names:
Device: Energy-Based Therapy
Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [Baseline (Day 1) to Day 56]
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect.
- Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point [Baseline (Day 1) to Day 56]
The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported.
- Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point [Baseline (Day 1) to Day 56]
The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-Documented clinical diagnosis of rosacea.
Exclusion Criteria:
-
History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled cardiovascular disease, or any other current uncontrolled systemic disease
-
Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or chronic recurring facial acne
-
Current treatment with monoamine oxidase (MAO) inhibitors
-
Current treatment with niacin ≥ 500 mg/day
-
Greater than 3 inflammatory lesions on the face
-
History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Dermatology and Laser Surgery | Sacramento | California | United States | 95819 |
| 2 | SkinCare Physicians | Chestnut Hill | Massachusetts | United States | 02467 |
| 3 | Skin Laser and Surgery Specialists of NY/NJ | Hackensack | New Jersey | United States | 07601 |
| 4 | Laser & Skin Surgery Center of New York Professional Corporation | New York | New York | United States | 10016 |
Sponsors and Collaborators
- Aclaris Therapeutics, Inc.
Investigators
- Study Director: Nancy Alvandi, Allergan
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- CMO-MA-MED-0530
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Arm/Group Description | Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) |
| Period Title: Overall Study | |
| STARTED | 46 |
| COMPLETED | 43 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Arm/Group Description | Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) |
| Overall Participants | 46 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
51.1
(12.38)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
36
78.3%
|
| Male |
10
21.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
3
6.5%
|
| Not Hispanic or Latino |
43
93.5%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
46
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
46
100%
|
Outcome Measures
| Title | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect. |
| Time Frame | Baseline (Day 1) to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Arm/Group Description | Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) |
| Measure Participants | 46 |
| TEAES |
5
10.9%
|
| Treatment Emergent Serious Adverse Events |
0
0%
|
| Title | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point |
|---|---|
| Description | The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported. |
| Time Frame | Baseline (Day 1) to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Arm/Group Description | Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) |
| Measure Participants | 46 |
| Day 1 -1 hour post dose |
8
17.4%
|
| Day 3-Pre Dose |
21
45.7%
|
| Day 3-1 hour post dose |
37
80.4%
|
| Day 3-3 hour post dose |
42
91.3%
|
| Day 3-6 hour post dose |
37
80.4%
|
| Day 3 -post dose any hour |
43
93.5%
|
| Day 29 Pre Dose |
18
39.1%
|
| Day 29-1 hour post dose |
14
30.4%
|
| Day 31 Pre Dose |
26
56.5%
|
| Day 31 -1 hour post dose |
38
82.6%
|
| Day 31-3 hour post dose |
39
84.8%
|
| Day 31-6 hour post dose |
38
82.6%
|
| Day 31 -any hour post dose |
42
91.3%
|
| Day 56 -Pre Dose |
30
65.2%
|
| Day 56-1 hour post dose |
30
65.2%
|
| Day 56-3 hour post dose |
40
87%
|
| Day 56 -6 hour post dose |
39
84.8%
|
| Day 56 -any hour post dose |
40
87%
|
| Title | Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point |
|---|---|
| Description | The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported. |
| Time Frame | Baseline (Day 1) to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Arm/Group Description | Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) |
| Measure Participants | 46 |
| Count of Participants [Participants] |
3
6.5%
|
Adverse Events
| Time Frame | Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Oxymetazoline + Energy-Based Therapy | |
| Arm/Group Description | Participants will receive energy-based therapy (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%. Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) | |
All Cause Mortality |
||
| Oxymetazoline + Energy-Based Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/46 (0%) | |
Serious Adverse Events |
||
| Oxymetazoline + Energy-Based Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/46 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Oxymetazoline + Energy-Based Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/46 (10.9%) | |
| Cardiac disorders | ||
| Tachycardia | 1/46 (2.2%) | 3 |
| General disorders | ||
| Face Oedema | 1/46 (2.2%) | 1 |
| Infections and infestations | ||
| Rash Pustular | 2/46 (4.3%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Dermatitis Contact | 2/46 (4.3%) | 2 |
| Rash Papular | 1/46 (2.2%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. David Gordon |
|---|---|
| Organization | Aclaris Therapeutics |
| Phone | 484-540-6273 |
| dgordon@aclaristx.com |
- CMO-MA-MED-0530